A Couples Approach to Enhance Breast Cancer Survivorship (CanThrive)

October 25, 2016 updated by: University of North Carolina, Chapel Hill
The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27708
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with early stage breast cancer within last year
  • No history of breast cancer, or other cancers in last 5 years (except skin cancer)
  • Living together in a committed heterosexual relationship
  • read and speak English
  • Agree to participate

Exclusion Criteria:

  • Stage 3b and above breast cancer
  • Notable psychopathology, including severe depression with suicidality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cancer-Focused Relationship Enhancement
Behavioral: Cancer-Focused Relationship Enhancement
Couples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues.
Experimental: Couple's Cancer Education
Behavioral: Couple's Cancer Education
Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.
No Intervention: Usual Care
Cancer-Related Community and Internet Resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
Time Frame: Pre, post, 6 month follow-up, 12 month follow-up
Pre, post, 6 month follow-up, 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Observational coding of couples social support and decision making conversations
Time Frame: pre, post, 6 month follow-up, 12 month follow-up
pre, post, 6 month follow-up, 12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Cancer Institute (NCI)
Duke University

Investigators

  • Principal Investigator: Donald H Baucom, Ph.D., University of North Carolina, Chapel Hill
  • Principal Investigator: Laura S Porter, Ph.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

April 22, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0977
  • 1R01CA107477-01 (U.S. NIH Grant/Contract)
  • LCC 0402 (Other Identifier: UNC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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